New study provides ‘substantial evidence’ paclitaxel-coated devices are safe when treating lower-limb PAD

Medtronic has received FDA approval for its IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter. FDA clears new drug eluting balloon, drug-coated balloon.

Medtronic's IN.PACT 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter.

Research published in 2018 caused many in the cardiology community to shy away from using these devices, and the FDA even issued warnings about their safety. However, new data suggest paclitaxel-coated balloons and stents are safe. 

FDA approves Medtronic’s next-generation TAVR system with new frame design

Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The larger coronary access window in the frame of the Evolut FX+. Image courtesy of Medtronic.

The larger coronary access window in the frame of the Evolut FX+. Image courtesy of Medtronic.

The Evolut FX+ TAVR system includes an updated diamond-shaped frame, which was made four times larger than previous models to offer improved coronary access. It was also designed to provide more space for operators to guide and maneuver the catheter during procedures.